FDA 510(k) Application Details - K012823

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K012823
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 555 13TH STREET, N.W. WASHINGTON, DC 20004-1109 US Other 510(k) Applications for this Company
Contact	JONATHAN S HAHAN Other 510(k) Applications for this Contact
Regulation Number	882.5810   More FDA Info for this Regulation Number
Classification Product Code	GZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2001
Decision Date	11/14/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review